Restorex for Peyronie's - 3 month data

Restorex® for PD, 3 Month Data

A randomized, controlled clinical trial using the RestoreX device in men with Peyronie’s disease was completed at Mayo Clinic. Clinical results were published in The Journal of Urology in September 2019.

The results are summarized below.

Study Design

The study randomly assigned 110 men to one of four treatment categories:

1. No treatment (control)
2. RestoreX 1, 30-minute treatment/day
3. RestoreX 2, 30-minute treatments daily (total of 60 minutes)
4. RestoreX 3, 30-minute treatments/day (90 minutes total).

 

The study was designed with a “control” group that did not use any therapy allowing for a direct comparison between RestoreX and the “no treatment” group. The study is one of only two randomized, controlled studies evaluating traction therapy in men with Peyronie’s disease. It will be the largest study ever conducted using traction therapy in men with PD and is the only randomized, controlled trial evaluating the use of traction for 2, 30-minute treatment sessions per day. It is also the only study to incorporate an “intent to treat” analysis meaning results were presented for all men who entered the study, not just those doing the treatment perfectly.

The characteristics of the men in the active treatment groups were well matched to those of the men in the control group allowing for accurate comparisons of treatment success. Most notably, on average men had been diagnosed with PD for just under 4 years, the average primary curvature was 45 degrees and nearly two-thirds of the men in the trial had tried some PD treatment already.